Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate and Severe Nasolabial Folds

August 24, 2022 updated by: Galderma R&D

A Randomised, Multi-center, Evaluator-blinded Study in China to Evaluate the Efficacy and Safety of Restylane Perlane Compared to Restylane for Correction of Moderate to Severe Nasolabial Folds

The purpose of this study is to determine the safety and efficacy of using Restylane Perlane compared to Restylane for correction of moderate to severe nasolabial folds (NLF) in a Chinese population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
      • Wuhan, China
      • Zhejiang, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chinese origin
  • Subjects intent to undergo correction of both NLFs with a Wrinkle Severity Rating Scale (WSRS) of 3 on both side or 4 on both side.
  • Subjects willing to abstain from other facial plastic surgical or cosmetic procedures during the study period.
  • Singed Informed Consent

Exclusion Criteria:

  • Subjects with traumatic scars or ongoing active skin disease in the area to be treated
  • Permanent inplant or filler, including fat injection placed in the area to be treated
  • Previous tissue augmentation therapy in the NLFs with non-permanent filler within 12 months prior to inclusion
  • Any medical condition in the opinion of the treating investigator who will make the subject unsuitable for inclusion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Restylane Perlane
Single injection and optional touch up injection with Restylane Perlane in NLF
Device: Restylane Perlane
Intradermal injection
Active Comparator: Restylane
Single injection and optional touch up injection with Restylane in NLF
Device: Restylane
Intradermal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at 6 Months
Time Frame: 6 months
The Wrinkle Severity Rating Scale (WSRS) is a 5-graded scale with grades 1-5 ranging from absent (1) to extreme (5). A clinical significant improvement is defined as at least 1 grade improvement (lowering in grade).
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galderma R&D

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

April 23, 2015

First Submitted That Met QC Criteria

April 28, 2015

First Posted (Estimate)

May 4, 2015

Study Record Updates

Last Update Posted (Actual)

August 26, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 43CH1408

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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